Far from a straight line but still on course

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Far from a straight line but still on course

Post by huntingonthebluffs » Sun Feb 17, 2019 11:47 pm

While we don’t know all the details or even some of the most critical material facts, I think most agreed the JS scenario for success via the JNJ/Janssen CLA was likely the best path forward based on events and knowledge at the time in 2014. And on many levels it was confirmation that we had something of great purpose and value in the Imetelstat drug. Once the agreement was signed we knew there was limited recourse but to play it out and see where it would take us, albeit positive with JNJ/Janssen, Imetelstat would succeed and be the most expedient path forward. Of course hindsight can be closer to 20-20, but only if we know all the details and material facts.

After picking up the pieces following the 9-27-18 shock, interestingly the door to approval seems more wide open and pervasive given recent ASH and investor conference presentations, FDA statements around MOS, acceleration, etc.

Now post CLA discontinuation, most again likely agree the Geron’s “standalone” plan is a reasonable starting point. Next steps have been laid out and likely using the JNJ/Janssen MDS CT framework and base establishments (i.e. dosages, endpoints, trial sites, patients, CRO, investigators, etc. ) in initiating the PIII, albeit, new CT timeframes are likely worst case. The current set up provides an easy stretch to significantly, maybe radically, improve on with some CT tweaking on primary endpoints and additional FDA designations to accelerate outcomes. Where we go with the MF R/R CT is not certain but strategy-wise could press the FDA into taking actions on accelerations and advanced designations in light of MF patients having no other options, especially given Geron’s decision to focus away from MF due to financial realities. I think this could this be a poker play to force FDA’s hand on MF knowing the efficacies of Imetelstat? Additional CTs will likely find their way into daylight as well along with future partnerships.

So progress is occurring and at a seeming decent but measured pace. Yet even obvious positives (i.e. new personnel, highly recognized medical doctor advocates, highly ranked CRO, meetings with the FDA, ever incrementing CT endpoints, eminent PIII(s), etc.) are second guessed “as there are endless reasons to question everything including areas clearly not based on confirmation bias. Obviously, there has been a major loss of trust in JNJ/Janssen, Geron, the FDA, the SEC, etc. However, we might be wise to place the majority of the mistrust at the feet of those “most responsible”, which while likely not blameless, doesn’t include Geron.

While many rely on what I would classify as “fake wisdom”, I find no documented factual justification in saying that JS has purposely held the stock pps down so he can amass options. And BTW, options are a legitimate part of his compensation so as a member of the executive suite, they have been earned and I would view as “skin in the game” and are not deviating from the corporate model used largely in the USA. And while, some on the boards claim the option grants as “excessive” they are not illegal, and I believe has mostly become a mantra of the frustrated and short bashers given that we are now on a clear path to approval.

So does the greedy executive suite and BoD need more cheap options? Does JS specifically need 5 more years to accumulate options in order to have a comfortable retirement? Can anyone specifically prove that JS is not doing his job by extrapolating from a couple examples of only taking a few basic questions in CC’s or based on his public speaking skills or compensation given the Geron vessel is still quite ocean worthy and steaming forward under his captainship? Some for their own egos on other boards seem to repeatedly convey unproven scenarios as reality. “Their experience” alone justifies such scenarios, and importantly affords them to have something to bash and claim the dots are connected. Unproven claims and entirely justified by their stated exemplary business / investing success and / or longevity of watching this drama play out. Seems to me to be another type of confirmation bias altogether.

So does this pandering justify bringing in a new CEO and BoD, while we know that much has happened over Geron’s 25+ years, JS has been the most effective in establishing a runway to achieve reasonably certain commercialization, not a BO like he supposedly was brought in to do, but true commercialization which he supposedly wasn’t qualified to do. Maybe he is capable and qualified to do either or both but maybe not as perfectly as any of us would want. My guess is he knows how to get both jobs done and what talent he needs on board to effectively execute the strategy.

So now what is the so called new “go-go CEO” with a new earth shaking, energetic sales pitch going to have in it that will drive the CT’s faster, make the FDA more responsive, make big pharma more willing to partner or buy out little Geron, speed up patient responses, drive patients and insurance companies to clamor for approval, etc. Well such rhetoric looks good on paper of course, but many of us have been in and around sales much of our careers and recognize that most executives worth their pay know that hoopla is basically just trying to sell an illusion versus the real product in an effort to convince people to jump at shiny things. So maybe that works well when the target is fish or even retail consumers, not so much when the target is a big pharma executives and BoDs.

So on another front, JS and BoD’s have been keeping Imetelstat a secret to keep the pps down. And for 7 years straight! Really??? I am in my 70’s and have many friends in the 60-70’’s, and to a person, we don’t misuse or “burn daylight” lightly or leave our legacies to chance. I would bet heavily that JS isn’t either! I personally have to get up from my chair and go for a walk to clear my head when I read such crap, maybe those spewing should do the same, unless of course they are true bashers and selling stock short, in which case their goal is disinformation. In which case, they are tempting bad karma and our positive, maybe even rational, thinking is the enemy.

The bottom line might be that retail investors, as many of us suspected, do not have a strong hand in influencing JS/Geron. After all, they are the experts, in the know, own the responsibility and yes, have the most skin in the game. Given the meager contingency of ownership willing to step up, as demonstrated in biopearl’s effort to assess if we could somehow garner a BoD seat and apply a more effective influence, acceptance of our limited role now seems more rationale. It appears that our primary means of voicing constructive thoughts are via emails / phone calls to Geron IR and/or written correspondence to the BoD and possibly a comment or question at the annual shareholders meeting. While this is possibly discouraging, it appears to be our current reality and I think we would be wise to go with it. Our communications with the FDA and SEC are also likely not as effective as anyone hoped but never the less our reality and should be used. As far as investigations into any wrong doing, doesn’t appear to be anything happening in that space either other than the noise created by spinning wheels. So if or until we actually have corralled enough “skin in the game” I will continue to do my own due diligence, follow the boards, communicate as an individual investor to the powers to be, keep the faith and acquire more shares in Geron accordingly.

Again, I usually get a little long winded. I was actually only getting started but sometimes mercy is the better part of valor…

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Re: Far from a straight line but still on course

Post by bucbeard » Mon Feb 18, 2019 1:13 am

Yet another thought-provoking and rational piece by HOTB! You bring true value to our Geron world.

I agree whole-heartedly, am pleased with 2019 actions and continue to exercise patience with JS, even while still staying vigilant for any legit signs of mismanagement or disregard.

Just as you say, "Far from a straight line, but still on course"

Thank you.

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Re: Far from a straight line but still on course

Post by 1bordersooner » Mon Feb 18, 2019 5:13 am

You're never "long winded" Thanks

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Re: Far from a straight line but still on course

Post by mistergern » Mon Feb 18, 2019 8:45 pm

Well said HTB. The current obsession with JS in SA is beyond overdone. We're due for a little unanticipated good luck. Holding strong.

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Re: Far from a straight line but still on course

Post by cheng_ho » Mon Feb 18, 2019 9:10 pm

>"Obviously, there has been a major loss of trust in JNJ/Janssen, Geron, the FDA, the SEC, etc."


>"our primary means of voicing constructive thoughts are via emails / phone calls to Geron IR and/or written correspondence to the BoD and possibly a comment or question at the annual shareholders meeting."

So Huntington thinks that we can save ourselves by complaining to the Chairman of the BoD (Scarlett) about the inaction of the CEO (Scarlett).

Somehow that doesn't restore my "trust".

The only hope is that the new GERN technical staff can turn the company back into a working organization. Trying to beg Scarlett to replace Scarlett doesn't make a lot of sense ;)

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Re: Far from a straight line but still on course

Post by huntingonthebluffs » Tue Feb 19, 2019 7:44 am

Well I agree that we are and should be alert to all things management and stewardship related with JS, his BoD as well as the team being assembled. Most of us are concerned with the deafening silence about the 9-27-18 breakup, and more deafening silence regarding the momentous Dr. Tefferi days and phantom Phase I results, the seeming reluctance to talk about results from the Phase II’s beyond “Imetelstat deserve more study”…

However, I think we might do well to imagine walking in JS’s shoes for a while. I know some of you can conjure more interesting scenarios but one might be that if I’m JS, and I may just be off the hook here. but he likely believes Imetelstat is possibly the most disruptive science to ever come along in the fight against cancer, period (i.e.” Imetelstat is bigger than all of us”). Yes, there are other contenders, CAR-T certainly comes to mind and many big pharma’s have their lab secrets re: immunotheraphy, RNA therapeutics, etc. and their billions invested in labs, CTs and marketing / insurance networks. But if I (JS) have patents for the crown jewels and think about Imetelstat being disruptive in the face the $billions invested in new science and current/future revenue streams at some risk to a new kid on the block, maybe I’d do well to keep my head down and work as quietly as possible to get close to approval before ramping up the storyline and banjos that Imetelstat clearly deserves.

So why would JS do that, well for one, as fictitious as it might be, I think we have all heard the stories of how great science gets suppressed in the trenches by big pharma and Wall Street henchmen. After all who really has weighty influence over the FDA, regulations, financing and so on? Certainly big pharma and Wall Street come to mind.

So realistic or not, I personally think there are reasons for JS keeping a low profile and strictly talking about science in muted terms. Otherwise I find it hard to conjure up anything that holds together for me about the many unexplainables found in the “Getting Imetelstat to Market” mystery series. Regardless whatever is going on here is probably “stuff we couldn’t make up”. And please don’t throw that JS and his rocking chair do nothing bunk back at me, it’s a lot more complicated than that!

Now if someone, and I hope there are a few “someones” can explain how to and can amass a collective amount of “skin in the game” to exert real influence over the powers to be, i.e. not just JS and Geron, then please lay it out and take a leadership role instead of spewing. And BTW, karagozoglu12345 has a thread on ImetelChat called “Brainstorm thread for activist role” just waiting for thoughtful and creative posts.

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Re: Far from a straight line but still on course

Post by ashah » Wed Feb 20, 2019 10:19 pm

First, I am a loser - Lost about 500K of very hard earned savings from my 401K. I start with this statement as a disclaimer, to highlight my limitations/failures.

I continue to believe in IM and JS. Besides prior post, I will share that if we put ourselves in JS shoes, then we have to be really careful. A lawyer is dime a dozen, and anything (optimistic) that JS says can, and will be used against him - under the claims that he tried to influence the market.

As an executive of a company, I know that his first responsibility is to "Do the right thing" - which is what JS seems to be doing by focusing on the Pivotal (P3) trials.

Finally, I strongly believe that either we are part of the solution, or part of the problem. There is NO INNOCENT bystander. I believe that there are things that we can do - which I am happy to post under a seperate cover.

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Re: Far from a straight line but still on course

Post by huntingonthebluffs » Thu Feb 21, 2019 4:41 am

ashah thanks for your thoughts on this thread. I assume you have contacted Geron HR directly and forwarded your resume specifically to HR. I would certainly concur that believing in the drug and thinking outside the box to accelerate the process to commercialization and finding ways to cost effectively expand the scope are paramount. Hopefully you can share your perceptions with us on why JS and company are guarded with their comments on the JNJ/Janssen arrangement and sharing details of CT information / strategy. If as you noted, the legal implications are overwhelming to the point of needing to avoid sharing very little with the retail shareholders outside of basic scientific results, then many here will find that reality challenging at best.

I would also encourage you to continue to share your enthusiasm and constructive thoughts on how to proceed forward, as well as encourage your peers to do likewise.

Also I think you will find most on ImetelChat are positive and constructive with their comments as you have been. Obviously we can all recognize the one in this thread that basically shows up as a lemon on a slot machine bar. Other than being a point of frustration, we recognize they are unable to add value to any conversation and best to avoid wasting any effort trying to reason given the intent is to twist and negate what we do here and elsewhere as well. While one might want to respond, what I think about it is not printable here. Not sure biopearl will allow this comment to stand but I'm not sure I would either.

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Re: Far from a straight line but still on course

Post by biopearl123 » Thu Feb 21, 2019 7:53 pm

Ashah and Hunt (as always,--censorship? preposterous say what you will--within reason of course!), thank you for these contributions to the board. Ashah, I can assure you you are in good company and many here have losses that exceed your own. I do think Scarlett's hands are tied until he has full control of the company back in his hands. He is also understandably cautious in this land of lawyers but should be more forthcoming in the near future. It is hard to envision Dr. Rizo, one of the originators of the venetoclax/imet patent not wanted to get something new into clinical trials. A surprise in the area could be lurking. Also there have been subtle changes in the clinical trial site as it has stood for years, namely the clarification of the ambiguous PII/III status back to PII where it belonged. The only justification for having this study set up this way was an initial anticipation of rapid and seamless movement from PII to PIII. As we know this did not happen. I can think of two possible reasons. One is the study design changed significantly and was reworked and the other is that the study design changed significantly and was reworked and would be accompanied by a post market approval. This latter idea is probably a fantasy but one that to my mind, given the excellent PII results and the protestations of the FDA re getting new drugs to market with a simplified path, is not impossible. MF should be a done deal. The ethics of requiring a true control are in a future study in end stage patients, should instead allow for some recognition of the value of the data as it stands now. This company is about to double in size, get a European partner and start a PIII (these events are almost a surety). I think other added value events may also be pending. bp

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